Bempedoic acid / ezetimibe Medicine 05 December 2023 Extended indication Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk. Therapeutic value No estimate possible yet Total cost € 111,663,200.00 Registration phase Registered and reimbursed Product Active substance Bempedoic acid / ezetimibe Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Other medication for cardiovascular diseases Extended indication Extension of indication to include treatment of adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk. Current proprietary name Already available biosimilars / generics Proprietary name Nustendi Manufacturer Esperion Portfolio holder Daiichi Sankyo Mechanism of action Other Route of administration Oral Therapeutical formulation Film-coated tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Esperion is een samenwerking gestart met Daiichi Sankyo voor het in de handel brengen van bempedoic acid. "First-in-class, small-molecule compound with a dual mechanism of action, inhibiting ATP citrate (pro-S)-lyase and stimulating AMP-activated protein kinase (AMPK). This inhibits fatty acid and cholesterol synthesis, and enhanced fatty acid oxidation." Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date August 2023 Expected Registration May 2024 Orphan drug No Registration phase Registered and reimbursed Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie maart 2024 Therapeutic value Current treatment options Losse tabletten bempedoinezuur en ezetimibe Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De meerwaarde van deze combinatietherapie hangt af van de uiteindelijke prijs. De prijs van een jaarlijkse behandeling met losse tabletten bempedoinezuur en ezetimibe kan rond de € 730 kosten (2). Als de prijs van dit middel gelijk of lager wordt kan er een meerwaarde zijn in toedieningsgemak en naleving van de behandeling. Duration of treatment Frequency of administration 1 times a day Dosage per administration References NCT02993406 (1); Medicijnkosten.nl (2) Additional remarks Expected patient volume per year Patient volume < 139,579 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank; GVS advies bempedoïnezuur Additional remarks Er zullen ongeveer 139.000 patiënten in aanmerking komen. Expected cost per patient per year Cost € 600.00 - 1,000.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Fabrikant Additional remarks De prijs van de PCSK9 antilichamen liggen rond de €6.000 per patiënt per jaar (niet rekening gehouden met het financieel arrangement). Het betreft hier een small molecule dat oraal beschikbaar is (tablet). De verwachting is dat de kosten veel lager zullen zijn dan de PCSK9 antilichamen. De fabrikant geeft aan een prijs van €600 tot €1.000 te verwachten. Dit is nog niet definitief. Potential total cost per year Total cost € 111,663,200.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks